Method for securing tissue

ABSTRACT

An apparatus and method is disclosed for securing tissue to a bone comprising a novel screw anchor for insertion into a bone by a novel rotational driver. The screw anchor and rotation driver enables the screw to be completely embedded into the bone while permitting a suture to be threaded through a transverse aperture in the screw. The rotation driver facilitates insertion and engagement of a capture with one of a series of protuberance formed along a length of a suture. In addition, the method is disclosed of forming the series of protuberance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Division of U.S. application Ser. No. 14/203,846filed Mar. 11, 2014. U.S. application Ser. No. 14/203,846 filed Mar. 11,2014 claims benefit of U.S. provisional application Ser. No. 61/778,350filed 12 Mar. 2013. All subject matter set forth in U.S. applicationSer. No. 14/203,846 filed Mar. 11, 2014 and U.S. provisional applicationNo. 61/778,350 filed 12 Mar. 2013 is hereby incorporated by referenceinto the present application as if fully set forth herein.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to surgery and more particularly to an apparatusand method for securing tissue comprising a novel screw anchor androtational driver for securing a suture to a surgical button, a pledgetor a capture.

Description of the Related Art

In recent years the use of captures have found increased use in thesurgical art. Typically, a capture is used in association with a suturefor securing an end of the suture without the need for tying a knot inthe suture. The use of a capture has several advantages over thetraditional tying of a suture. Firstly, a capture will secure a suturefaster than tying a traditional knot. Secondly, a capture will generallyyield more consistent holding strength relative to a traditional knot.Thirdly, a capture can be used in arthroscopic surgery where spacelimitation makes knot tying difficult for a surgeon.

The following prior art are examples of the development of captures andthe like, including anchors, fasteners screws for the surgical art.These prior art examples may be used in various types of surgeryincluding medical, veterinary and dental implants.

U.S. Pat. No. 4,898,156 to Gatturna, et al. discloses a suture anchorfor anchoring one end of a conventional suture to bone comprising acoupling member, with at least one barb made of a resilient elasticmaterial projecting from said coupling member, and structure for use inattaching one end of a suture to said suture anchor. The coupling memberand the at least one barb are adapted to securely anchor one end of thesuture in bone when the suture is attached to the attachment structure,so that the other end of the suture extending outside the bone can beused to attach objects to the bone. A novel application tool is alsoprovided.

U.S. Pat. No. 5,733,307 to Dinsdale discloses a bone anchor with asuture trough for attaching bone to tissue using a suture. The boneanchor includes a threaded bone anchor body having a major diameter, aminor diameter, a tip, and a drive head. A suture trough is formedwithin the anchor body with a width greater than or equal to thediameter of the suture and a depth below the minor diameter greater thanor equal to the diameter of the suture. A suture passageway connects theopposing portions of the suture trough. The suture seats within thesuture trough during insertion of the bone anchor into the bone.

U.S. Pat. No. 5,370,661 to Branch discloses a method for attachingtissue to a bone, which includes the use of a filament member and a headmember which engages the filament member and holds a tissue in place.Also provided is a device and method for repairing a break in tissue,which indicates the use of a filament member and at least one memberwhich engages the filament member.

U.S. Pat. No. 5,413,585 to Pagedas discloses a self locking suture lockhaving a first suture thread opening in which the thread is securedbefore the surgical stitch and a cone shaped second stitch lock openingthat is larger at the front side than at the back side, and designed toreceive suture thread in only one direction, thereby locking it againstwithdrawal after the stitch to complete and lock it without the need fora surgical knot. A tongue in the second opening will allow passagethrough the cone shaped second opening from front side to back side butnot allow passage from back to side to front side or pulling out ofsecond opening once threaded. The front side of the self locking suturemay be distinctively colored so that a surgeon will know which side ofthe suture lock will accept the suture thread. The first opening maytake the form of a deformable slot, a pair of openings, or other forms.The tongue may engage the edge of the second opening, a slot, or otherunidirectional lock structures.

U.S. Pat. No. 5,584,835 to Greenfield discloses a two-part device forsuturing soft tissue to bone. The device employs a bone anchor which isinstalled in the bone and a suture anchor which is coupled to the softtissue and then engaged with the bone anchor. The engagement of thesuture anchor with the bone anchor is readily reversible so as to permitadjustments in the placement of the sutures. In the practice of theinvention, no step is irreversible except the drilling of the bone holethat accepts the bone anchor. A special tool is described forfacilitating the installation of a bone anchor having a round internalcross-section. The suture anchor can be installed with the applicationof only direct pressure, and can be disengaged by counterclockwiserotation, with the use of a disengagement tool, such as a screw driver.Sutures are threaded through apertures in the suture anchor, and theengagement of the sutures is enhanced by a friction fit between thesuture and bone anchors.

U.S. Pat. No. 5,938,686 to Benderev, et al. discloses a bone anchorimplantation device positioned over a bone, and a bone anchor installedin a bone.

U.S. Pat. No. 5,948,000 to Larsen, et al. discloses a system for sutureanchor placement including an apparatus having a handle portion and anoperating portion. The handle portion includes a spring, a needle park,and a member for releasably holding a length of the suture. Theoperating portion includes a sheath tube and a plunger rod slidablydisposed within the bore of the sheath tube. The plunger rod is fixedlymounted at its proximal end to the handle. The suture anchor isreleasably engaged to the distal end portion of the plunger rod. Thesheath tube is mounted to the handle and movable with respect to thehandle between a distal position and a proximal position, the sheathtube being resiliently biased to the distal position by the spring andmovable to the proximal position in response to proximally directedforce of sufficient magnitude applied to the distal end of the sheathtube. The sheath tube has a portion with an outer diameter greater thanthe diameter of the hole in the bone such that when the installationtool is pressed toward the bone, the sheath tube retracts into thehandle and the suture anchor is advanced into a hole previously made inthe bone. The suture, initially held in a taut configuration, isreleased in response to movement of the sheath tube to its proximalposition.

U.S. Pat. No. 6,013,083 to Bennett discloses tom tissue such as arotator cuff positioned on the bone exterior by a tissue grasper. Acannula is inserted through the skin substantially to the torn tissue. Adrill guide is inserted into the cannula, a drill bit is inserted intothe drill guide, and a hole is drilled through the torn tissue andcompletely through the bone. The drill bit is removed and an innercannula is passed through the drill guide until its distal end isengaged on the torn tissue or alternatively passed through the holeuntil its distal end is at the far end of the drilled hole. A softtissue anchor having expandable wings at its distal end and suturessecured to an eyelet at its proximal end is releasably connected to thedistal end of a tubular deployment tool with the free ends of thesutures extending through the deployment tool. The deployment tool ispassed through the inner cannula and drilled hole until the expandablewings clear the far end of the hole a sufficient distance to allow thewings to expand to a diameter larger than the diameter of the drilledhole. The deployment tool, inner cannula, drill guide, and cannula areremoved and tension is applied to the suture to engage the expandedwings of the anchor on the exterior surface of the bone surrounding thedrilled hole. A button is run down on the sutures through the cannulaand secured on the torn tissue by the sutures such that the tom tissueis secured to the bone and the sutures are anchored to the hard exteriorsurface of the bone by the expanded anchor.

U.S. Pat. No. 6,015,410 to Tormala, et al. discloses a bioabsorbablesurgical implant for use in supporting soft tissue in a superiorposition in the body. The surgical implant includes a shaft thatconnects the implant to a bone or hard tissue and a head secured to theshaft. The head of the implant has a concave lower surface so that asuture (or sutures) can easily be wound around the shaft below the headand locked to this position by tightening the head against bone or hardtissue and by pushing or turning the shaft into the bone or hard tissue.The connected shaft and head are formed from a resorbable polymer,copolymer, polymer alloy or composite, which maintains a specifiedstrength for a period of time at least equal to a healing period for thepatient. Thereafter, the surgical implant is substantially resorbed bythe body over a period of time needed for healing. The surgical implantis particularly adapted for use in endoscopic face and/or brow liftsurgery and other endoscopic cosmetic, plastic and reconstructivesurgical procedures, where sutures are applied for tissue lifting.

U.S. Pat. No. 6,117,162 to Schmieding, et al. discloses a corkscrewsuture anchor having a continuous thread spiraling around a taperingcentral core. At the distal end, the suture anchor terminates in arounded point. At the proximal end of the suture anchor is an eye forreceiving suture. The suture anchor has a large thread surface per turnof thread. Anti-backout ridges can be formed on the front and/or backfaces of the threads. A driver for the suture anchor is provided, thedriver including a shaft having a central axis, a length, a distal end,and a proximal end. The shaft is provided at its distal end with anopening aligned with the central axis of the shaft, for receiving thehexagonal proximal end of the suture anchor. One or more suturesthreaded through the suture eye are threaded through the hollow tubularshaft. The suture is pulled into and captured by V-shaped notches on theproximal end of the handle to hold the suture anchor in place on thedistal end of the driver under the tension of the captured sutures.

U.S. Pat. No. 6,206,886 to Bennett discloses torn tissue such as arotator cuff positioned on the bone exterior by a tissue grasper. Acannula is inserted through the skin substantially to the torn tissue. Adrill guide is inserted into the cannula, a drill bit is inserted intothe drill guide, and a hole is drilled through the tom tissue andcompletely through the bone. The drill bit is removed and an innercannula is passed through the drill guide until its distal end isengaged on the torn tissue or alternatively passed through the holeuntil its distal end is at the far end of the drilled hole. A softtissue anchor having expandable wings at its distal end and suturessecured to an eyelet at its proximal end is releasably connected to thedistal end of a tubular deployment tool with the free ends of thesutures extending through the deployment tool. The deployment tool ispassed through the inner cannula and drilled hole until the expandablewings clear the far end of the hole a sufficient distance to allow thewings to expand to a diameter larger than the diameter of the drilledhole. The deployment tool, inner cannula, drill guide, and cannula areremoved and tension is applied to the suture to engage the expandedwings of the anchor on the exterior surface of the bone surrounding thedrilled hole. A button is run down on the sutures through the cannulaand secured on the tom tissue by the sutures such that the tom tissue issecured to the bone and the sutures are anchored to the hard exteriorsurface of the bone by the expanded anchor.

U.S. Pat. No. 6,214,031 to Schmieding, et al. discloses a corkscrewsuture anchor having a continuous thread spiraling around a taperingcentral core. At the distal end, the suture anchor terminates in arounded point. At the proximal end of the suture anchor is an eye forreceiving suture. The suture anchor has a large thread surface per turnof thread. Anti-backout ridges can be formed on the front and/or backfaces of the threads. A driver for the suture anchor is provided, thedriver including a shaft having a central axis, a length, a distal end,and a proximal end. The shaft is provided at its distal end with anopening aligned with the central axis of the shaft, for receiving thehexagonal proximal end of the suture anchor. One or more suturesthreaded through the suture eye are threaded through the hollow tubularshaft. The suture is pulled into and captured by V-shaped notches on theproximal end of the handle to hold the suture anchor in place on thedistal end of the driver under the tension of the captured sutures.

U.S. Pat. No. 6,293,961 to Schwartz, et al. discloses a device forlocking a suture in place without the need for tying knots once thesuture is placed within tissue. The device comprises an anchor having afront section and a rear section, a cannula extending through the frontand rear sections through which the suture extends, and a beadpositioned adjacent an end of the suture for locking the suture withinthe cannula.

U.S. Pat. No. 6,491,714 to Bennett discloses a surgical apparatus foranchoring and reattachment of torn tissue such as a rotator cuff againston the outer or exterior surface of a tissue substrate. The inventionincludes a tissue substrate anchor such as that having expandable wings,an elongated suture member securable at its proximal end to the tissuesubstrate anchor, and a torn tissue retainer lockingly attachable alongthe length of the suture member by mating interlocking structuretherebetween. Tension is applied to the free distal end of the suturemember while the tissue retainer is non-reversibly moved longitudinallyalong on the suture member to secure the tom tissue against the tissuesubstrate outer surface. A separate torn tissue gripping member may alsobe provided for broadened and enhanced tom tissue securement against thetissue substrate. In another embodiment, the tissue anchor is formed asa unit with the suture member enabling additional forms of tissue repairsuch as the closure of an internal meniscus tear or separation.

U.S. Pat. No. 6,533,802 to Bojarski, et al. discloses a method ofsecuring a tissue graft within a bone passage including providing agraft fixation member comprising a closed-loop having a pair of opposingloop sections and capturing a first loop section of the closed-loopwithin the fixation member. An opposing second loop section of theclosed loop is passed through an opening in the tissue graft, and thesecond loop section of the closed loop is secured to the fixationmember.

U.S. Pat. No. 7,303,577 to Dean discloses a method, system and apparatusfor augmenting the surgical repair of soft tissue injuries, in which afirst end of a bridge member attaches to a first portion of healthytissue, and a second end of the bridge member attaches to a secondportion of healthy tissue. The bridge member (or bridge members) used toaugment the soft tissue repair may be interconnected or functionindependently. Flexibility and elasticity of the bridge member aredetermined by the situation and may be altered to improve healing. Thedevice may be used in arthroscopic procedures, and may be manufacturedin a variety of lengths, or may be manufactured one length and be cut tothe desired length, or otherwise altered to provide an optimal length ofthe bridge member.

U.S. Pat. No. 7,530,990 to Perriello, et al. discloses a method ofsecuring a tissue graft within a bone passage including providing agraft fixation member comprising a closed double-loop having a pair ofdifferently sized loop sections and capturing both sections of theclosed-loop within the fixation member. The longer loop section ispassed through an opening in the tissue graft then is passed through thesmaller loop and thrown over the fixation member to form a knot.

U.S. Pat. No. 7,585,311 to Green, et al. discloses a method and devicefor securing soft tissue to a rigid material such as bone. A bone anchoris described that comprises a base and a top such that suture materialmay be compressed between surfaces on the base and top to secure thesuture to the anchor. Also described is an inserter that can be used toinsert the bone anchor into bone and move the anchor top relative to theanchor base to clamp suture material there between. Also described is asoft-tissue and bone piercing anchor and associated inserter. Methodsare described that allow use of the bone anchors to provide multiplelengths of suture material to compress a large area of soft tissueagainst bone.

U.S. Pat. No. 7,615,061 to White, et al. discloses a suture-loadingsystem, method and apparatus for loading a suture onto a bone anchor.The system comprising: a bone anchor comprising a suture leg-anchoringstructure and a plurality of body holes on the anchor; a suturecomprising a standing end portion and a working end portion; a standingend trackway to guide the standing end portion of the suture through thesuture leg-anchoring structure; and a working end trackway to guide theworking end portion of the suture through the body holes in the anchor.

U.S. Pat. No. 7,637,926 to Foerster, et al. discloses an innovative boneanchor and method for securing soft tissue, such as tendons, to bone,which permit a suture attachment that lies entirely beneath the corticalbone surface. Advantageously, the suturing material between the softtissue and the bone anchor is secured without the need for tying a knot.The suture attachment to the bone anchor involves the looping of alength of suture around a pulley within the bone anchor, tightening thesuture and attached soft tissue, and clamping the suture within the boneanchor. The bone anchor may be a tubular body having a lumen containinga plurality of suture-locking elements that clamp the suture therein.The locking elements may be thin and C-shaped. One or more locking plugsattached to separable actuation rods displace axially within the lumenand act on the locking elements to displace them radially. A generallyuniform passage through the locking elements in their first positionsconverts to a smaller irregular passage after the locking plug displacesthe elements to their second positions, thus effectively clamping thesuture. The bone anchor further may include locking structure forsecuring itself within a bone cavity.

U.S. Pat. No. 7,658,750 to Li discloses a suture anchoring system andmethod including a plurality of anchor members interconnected to form ananchor assembly with a suture extending therefrom. The anchor assemblyhas an insertion configuration wherein the anchor members are aligned ina substantially linear arrangement for delivery through an aperture inbodily tissue and an expanded configuration wherein the anchor membersare transitioned to a non-linear arrangement to prevent passage of theanchor assembly back through the aperture.

U.S. Pat. No. 7,658,751 to Stone, et al. discloses a suture constructionand method for forming a suture construction. The construction utilizesa suture having an enlarged central body portion defining a longitudinalpassage. First and second ends of the suture are passed through firstand second apertures associated with the longitudinal passage to form apair of loops. Portions of the suture lay parallel to each other withinthe suture. Application of tension onto the suture construction causesconstriction of the longitudinal passage, thus preventing relativemotions of the captured portions of the suture.

U.S. Pat. No. 7,662,157 B2 to Ahmad discloses a bone anchor including ascrew portion configured to penetrate a bone. The screw portion includesa retention thread extending at least part of a length of the screwportion and a tip at a first end of the screw portion. The bone anchorincludes a protrusion adjacent a second end of the screw portion. Thesecond end is opposite the first end of the screw portion. Theprotrusion comprises a plurality of external sides forming a shape and arounded interior surface enclosing a protrusion recess. The roundedinterior surface includes a recess thread configured to retain acomponent at least partially in the protrusion recess. The protrusionhas a maximum width that is less than a maximum diameter of the screwportion such that a shoulder is formed where the protrusion meets thesecond end of the screw portion.

U.S. Pat. No. 7,674,274 to Forester, et al. discloses a bone anchordevice for attaching connective tissue to bone comprising a disk adaptedfor insertion into a portion of bone to which the connective tissue isto be attached. The disk is movable between a bent orientation forpresenting a smaller cross-section and an expanded orientation forpresenting a larger cross-section. The bent orientation is utilized forinserting the disk through a small hole into a region of cancellous bonebeneath the cortical bone layer, after which the disk is actuated to itsexpanded orientation so that it will be permanently anchored in thecancellous bone, as it will be too large to return proximally throughthe hole in the cortical bone layer. Two embodiments are disclosed. In afirst embodiment, the disk is initially formed in the expandedorientation, of spring steel. In a second embodiment, the disk isinitially formed in the bent orientation, and spring steel is notrequired.

U.S. Pat. No. 7,686,838 to Wolf, et al. discloses a surgical anchordevice for the repair of a torn ligament or tendon, primarily theanterior cruciate ligament in the knee. The device is used to affix theligament within a femoral bone tunnel in the distal portion of the femurfrom the intra-articular surface. The device provides a pulley for asuture, wherein a free end of the suture may be pulled away from thedevice to draw the suture attached to the ligament graft within thefemoral bone tunnel securing the ligament graft within the bone tunnel.Installation of the device is provided by insertion of the devicethrough a tibial hole, through the femoral tunnel out of the lateralfemoral cortex, pulling the attached sutures simultaneously to flattenthe device against the lateral femoral cortex, attaching one end of thesuture to the ligament graft and pulling the other end of the sutureuntil the graft is situated properly within the femoral bone tunnel andtying the free end of the suture to retain the graft within the femoralbone tunnel.

U.S. Pat. No. 7,695,494 to Foerster discloses a device for attachingconnective tissue to bone. The device has a longitudinal axis andcomprises an annular toggle member and a body member disposed distallyof the toggle member, such that there is an axial space between thetoggle member and the body member. The toggle member is movable betweenan undeployed position wherein the toggle member has a smaller profilein a direction transverse to the axis and a deployed position whereinthe toggle member has a larger profile in the direction transverse tothe axis. When installed in a desired procedural site, in suitable bone,suturing material extends axially through a center aperture in theannular toggle member, without being secured to or contacting the togglemember. This approach permits a suture attachment which lies entirelybeneath the cortical bone surface, and which further permit theattachment of suture to the bone anchor without the necessity for tyingknots, which is particularly arduous and technically demanding in thecase of arthroscopic procedures.

U.S. Pat. No. 7,713,285 to Stone, et al. discloses a suture anchor foranchoring a suture in the selected portion of an anatomical portion forfixing a suture thereto. The suture anchor includes an anatomicalengaging portion and a suture engaging portion wherein both theanatomical engaging portion and a suture engaging portion are adapted tobe substantially disposed below an exterior of the anatomical portionafter implantation. Suture eyelets are provided in the suture engagingsection and a suture passage is formed to interconnect the eyelets toallow a suture to be easily threaded in the suture engaging section fromthe first eyelet to the second eyelet.

United States Patent Application 2002/0004668 to Bartlett discloses asuture anchor comprising a generally quadrilaterally shaped body havinga bore-abutting surface with a leading gripping edge at one end of thebore-abutting surface, a trailing gripping edge at the other end, and aclosing surface having an arcuate portion and a linear portion engagingthe leading and trailing gripping edges, respectively, generallyopposite the bore-abutting surface. The body further defines a suturebore extending transversely therethrough and an inserter bore adapted toreceive an insertion tool. A suture engages the suture anchor throughthe bore and is adapted to engage bodily tissue to be secured to thebone. Also provided are a knotless suture anchor configuration, anassociated insertion tool, and a suture anchor kit, as well as a methodof implanting a suture anchor in a bore in a bone.

United States Patent Application 2002/0004669 to Bartlett discloses asuture anchor comprising a generally quadrilaterally shaped body havinga bore-abutting surface with a leading gripping edge at one end of thebore-abutting surface, a trailing gripping edge at the other end, and aclosing surface having an arcuate portion and a linear portion engagingthe leading and trailing gripping edges, respectively, generallyopposite the bore-abutting surface. The body further defines a suturebore extending transversely therethrough and an inserter bore adapted toreceive an insertion tool. A suture engages the suture anchor throughthe bore and is adapted to engage bodily tissue to be secured to thebone. Also provided are a knotless suture anchor configuration, anassociated insertion tool, and a suture anchor kit, as well as a methodof implanting a suture anchor in a bore in a bone.

United States Patent Application 2002/0007196 to Bartlett discloses asuture anchor comprising a generally quadrilaterally shaped body havinga bore-abutting surface with a leading gripping edge at one end of thebore-abutting surface, a trailing gripping edge at the other end, and aclosing surface having an arcuate portion and a linear portion engagingthe leading and trailing gripping edges, respectively, generallyopposite the bore-abutting surface. The body further defines a suturebore extending transversely therethrough and an inserter bore adapted toreceive an insertion tool. A suture engages the suture anchor throughthe bore and is adapted to engage bodily tissue to be secured to thebone. Also provided are a knotless suture anchor configuration, anassociated insertion tool, and a suture anchor kit, as well as a methodof implanting a suture anchor in a bore in a bone.

United States Patent Application 2006/0058844 to White, et al. disclosesan internal tissue puncture closure method and apparatus providing alocking device for compressing and holding an external component such asa collagen sponge at a puncture situs. The locking device facilitatescompression of the external component in a first direction, but preventsor locks against retraction.

United States Patent Application 2006/0106422 to Del Rio, et al.discloses suture tying in a medical procedure including the use of ananchor that includes a suture locking device. The device includes asliding pin guided by axial side slots formed in the locking device thatforces the suture where the two ends thereof are inserted into theinterior of the suture locking mechanism to drive the captured sutureand pin to fit into a recess on the top of the suture locking mechanismsuch that the top of the pin binds the suture against the upper innersurface of the recess. The recess can be serrated to enhance the lockingcapability and the pin is polygonal shaped to provide side surfaces thatrun parallel to the wall of the recess to assure that the side portionof the pin does not fracture the suture and cause it to weaken. Thelocking of the suture is automatic upon the deployment of the anchorwhich actuates the pin into the locking position, thus eliminating thenecessity of manually knotting the suture and improving the cinching ofthe tissue to the bone. The suture locking mechanism is usable forattaching tissue to the bone, tying tissue to tissue and the like. Thedisclosure also includes the method of deploying the combined anchor andsuture locking device in a medical procedure.

United States Patent Application 2007/015651 to Guan, et al. disclosesan expanding plug for tendon fixation featuring a two-part system inwhich an expansion pin fits inside a fixation sleeve. The fixationsleeve is configured to expand diametrically to achieve interferencefixation of a graft tendon inside of a bone tunnel. Fixation sleeveexpansion is urged by a two-step engagement of the expansion pin. Thetendon graft is assembled to the expanding bolt and situated within abone tunnel. Passing suture is used to pull a joint-line end of theexpansion pin into the tunnel to partially expand the fixation sleeve atthe joint-line end. Pulling a graft end of the expansion pin toward thejoint line expands the fixation sleeve to place the expanding plug inthe fully deployed configuration.

United States Patent Application 2007/028375 to Hindrichs, et al.discloses an implant structure for use in pulling two soft body tissueareas closer together in a patient (e.g., two points along or adjacentto the patient's mitral valve annulus) including at least two tissueanchor structures that are respectively implantable into the two tissueareas. A tether structure links the two tissue anchors and can beshortened and held in that condition by a cinch structure. Bracingstructures are used between the anchors and the tether to help keep thelongitudinal axes of the anchors transverse to the tether axis even whenthe tether is under tension. The tether may be sheathed in a cushioningsleeve to help protect adjacent tissue from erosion by the tether.

United States Patent Application 2008/0082113 to Bishop, et al.discloses embodiments of apparatus and methods for tissue lifting, orfor correcting a ptosis condition caused by tissue stretching. In someembodiments a tissue is supported by a support member. In someembodiments, tension is applied to a support member through at least onesuspension member. The described embodiments provide examples of methodsand apparatus effective for use in lifting or otherwise applying tensionto various tissues, including tissues of the breast, buttock, thigh,arm, abdomen, neck and face.

United States Patent Application 2008/0234731 to Leung, et al. disclosesa suture anchor for approximating tissue to bone or other tissue. Thesuture anchor comprises an anchor member to fixedly engage the bone forsecuring the anchor member relative to the bone. A plurality of suturesare mounted to the proximal end of the anchor member so that the suturesextend outwardly from the anchor member. Each suture has a sharp pointeddistal end for penetrating the tissue and a plurality of barbs extendingfrom the periphery and disposed along the length of the body of thesuture. The barbs permit movement of the sutures through the tissue in adirection of movement of the pointed end and prevent movement of thesutures relative to the tissue in a direction opposite the direction ofmovement of the pointed end. At least one pointed distal end of at leastone suture comprises a needle.

United States Patent Application 2009/0248071 to Saint, et al. disclosesmethods and apparatus for use in supporting tissue in a patient's body.In some embodiments, the patient's breast is supported. In someembodiments, the methods provide ways of supporting and adjustingtissue, and the apparatus includes components and embodiments forsupporting and adjusting the tissue. Some embodiments include asupporting device, having a first portion, a second portion, and asupport member positioned between the first portion and second portion.Some embodiments include advancing the first portion of the supportingdevice into the body to a first location in the body; advancing thesecond portion of the supporting device into the body to a secondlocation in the body; securing the first portion of the supportingdevice at the first location; and shifting soft tissue in the body withthe support member.

United States Patent Application 2009/0287227 to Newell, et al.discloses methods, systems, devices and assemblies for treating apatient by: making an incision or puncture though the patient's skinover the abdominal cavity. An initial tract is established through anopening formed by the incision or puncture. An instrument is advancedthrough the tract; contacting a distal end portion of the instrumentagainst an inner surface of the abdominal cavity, and driving at leastone stitching needle through the inner surface of the abdominal cavity.The driving is continued until the at least one stitching needle exitsthe inner surface of the abdominal cavity. A suture anchor is carried byeach of the at least one stitching needle to a suture anchor at an exitlocation, respectively. Tension is applied to each of the sutures.

United States Patent Application 2010/0101526 to Bennett discloses asurgical suture system, suture, and tissue engaging member for tissuerepair and reattachment of tom tissue to a tissue substrate, medicalprosthesis or medical implant. The system includes the elongatedflexible suture member having a plurality of longitudinally spacedprotuberances along a length thereof and one or a plurality of thetissue engaging members each of which include two closely spaced apartlocking apertures sized and configured to receive one of the suturemembers passed therethrough or a unique single locking aperture to allowlongitudinal tensioning and/or restraining movement of the suture memberin only one direction through the locking apertures for suture membertightening.

United States Patent Application 2010/0160963 to Fallin, et al.discloses a system for attaching soft tissue to bone including ananchor, a suture, and a tissue retainer. The anchor may have a threadedtip that engages the bone, and a suture retention portion withpassageways arranged such that each of first and second anchor portionsof the suture can be drawn through the passageways along only a singledirection. The tissue retainer has passageways through which the suturecan freely move in either direction. Thus, the anchor and the tissueretainer may be attached to bone and tissue, respectively, and thesuture may be drawn to substantially irreversibly draw the bone andtissue together. In alternative embodiments, an anchor may receive onlyone portion of suture and/or one suture end may be affixed to theanchor. The anchor may alternatively permit free motion of the suture,while the tissue retainer permits passage of the suture along only onedirection.

United States Patent Application 2012/0101524 to Bennett discloses asurgical suture system for tissue repair and reattachment of torn tissueto a tissue substrate, medical prosthesis or medical implant. The systemincludes an elongated flexible suture member having a plurality oflongitudinally spaced protuberances along a length thereof and aplurality of tissue engaging members each including two spaced apartlocking apertures sized to receive the suture member passed therethroughto allow longitudinal movement of the suture member in only onedirection through the locking apertures for suture member tightening.

United States Patent Application 2013/0090686 to Covidien disclosesbarbed surgical sutures are provided which include an elongated body anda plurality of barbs extending therefrom. A bioactive agent is disposedwithin barb angles formed between the barbs and the elongated body. Thebarbs may be made from a shape memory polymer having a permanent shapewhich may be deformed to a temporary shape, such that barbs of thesuture extend at different barb angles in the different shapeconfigurations. The barb angles of the permanent shape may be greaterthan the barb angles of the temporary shape, thereby exposing and/orreleasing a bioactive agent after placement in tissue.

Although the forgoing prior art has contributed to the surgical art,none of these have provided a new system for securing sutures to atissue or a bone suitable for use in general as well as arthroscopic,endoscopic, laparoscopic or minimally invasive surgery.

Therefore, it is an object of the invention to provide an improved handtool comprising a rotation driver for rotationally inserting a screwwithin a bone.

Another object of this invention is to provide a novel screw suitablefor use with the rotation driver for completely embedding the screw intothe bone while permitting a suture to be threaded through a transverseaperture in the screw.

Another object of this invention is to provide a rotation driver forfacilitating the insertion and engagement of a capture with one of aseries of protuberance formed along a length of a suture.

Another object of this invention is to provide a method for forming aseries of protuberance along a length of a suture.

The foregoing has outlined some of the more pertinent objects of thepresent invention. These objects should be construed as being merelyillustrative of some of the more prominent features and applications ofthe invention. Many other beneficial results can be obtained bymodifying the invention within the scope of the invention. Accordinglyother objects in a full understanding of the invention may be had byreferring to the summary of the invention, the detailed descriptiondescribing the preferred embodiment in addition to the scope of theinvention defined by the claims taken in conjunction with accompanyingdrawings.

SUMMARY OF THE INVENTION

The present invention is defined by the appended claims with specificembodiments being shown in the attached drawings. For the purpose ofsummarizing the invention, the first embodiment of the invention relatesto an improved hand tool for rotationally inserting a screw within abone. The hand tool comprises a rotational driver having a handlesupporting a shaft extending from a proximal end to a distal end. Asocket is defined in the distal end of the shaft for receiving a head ofthe screw for rotationally inserting the screw within the bone. A firstand a second slot is located in the socket defining a first and a secondcutting edge for cutting the bone upon rotation of the rotational driverto simultaneously insert the screw and countersink the head of the screwwithin the bone and also allow suture from as receiving screw to passout from screw and along driver shaft without engaging sharpcountersinking edges of driver.

A second embodiment of the invention relates to an improved fastener forinsertion into a living tissue by a rotational driver. The fastenercomprises a screw body extending between a screw tip and a screw head.The screw head defines a socket shape in an outer periphery of the screwhead for enabling the rotational driver to rotationally insert the screwbody into the living tissue. A transverse aperture extends through thescrew body below the screw head. A first and a second channel is definedin opposed sides of the screw head and communicates with the transverseaperture for enabling a suture to extend through the first and secondchannels and the transverse aperture while the screw body is insertedinto the living tissue by the rotational driver. The first and secondchannels and the transverse aperture are dimensioned for enabling thesuture to be moved through the first and second channels and thetransverse aperture when the screw body is totally embedded into theliving tissue and allows for the shuttling of a suture through theembedded screw.

A third embodiment of the invention relates to a method of securing atissue to a bone with a suture. The suture has a series of protuberancesspaced apart along a length thereof. The method comprises the steps ofrotating a driver for driving a screw into the bone with the sutureextending through the transverse aperture in the screw. A first end ofthe suture is passed through a central aperture in the driver and isthreaded through a central aperture in a capture. The capture is pushedwith the driver along the suture to lockingly engage the capture withone of the series of protuberances for securing the first end of thesuture. A second end of the suture is secured for securing the tissue tothe bone.

A fourth embodiment of the invention relates to a method for forming aprotuberance on a suture comprising the steps of placing a suture toextend through a mold cavity. An adhesive is inserted into the moldcavity. The adhesive is permitted to cure in the mold. The suture andthe adhered protuberance is removed from the mold. Preferably, each ofthe mold cavities has a leading edge shape defined for cooperation withthe entrance aperture contour of the capture and a trailing edge shapedefined for cooperation with the reverse aperture contour of thecapture. Other methods include a process that requires the applicationof a melted substance-requiring substantial temperatures to placematerial onto a suture which can damage the suture itself, thistechnique includes the application of an adhesive that sets at ambienttemperature or some other method that do not affect the suture.

The foregoing has outlined rather broadly the more pertinent andimportant features of the present invention in order that the detaileddescription that follows may be better understood so that the presentcontribution to the art can be more fully appreciated. Additionalfeatures of the invention will be described hereinafter which form thesubject of the claims of the invention. It should be appreciated bythose skilled in the art that the conception and the specificembodiments disclosed may be readily utilized as a basis for modifyingor designing other structures for carrying out the same purposes of thepresent invention. It should also be realized by those skilled in theart that such equivalent constructions do not depart from the spirit andscope of the invention as set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the invention,reference should be made to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a top isometric view of a rotational driver and a screwincorporating the present invention;

FIG. 2 is a bottom isometric view of FIG. 1;

FIG. 3 is a top view of the rotational driver and screw of FIGS. 1 and2;

FIG. 4 is a side view of FIG. 3;

FIG. 5 is an enlarged view along line 5-5 in FIG. 4;

FIG. 6 is an enlarged view of a portion of FIG. 4;

FIG. 7 is an enlarged sectional view along line 7-7 in FIG. 4;

FIG. 8 is a top view similar to FIG. 3 illustrating the rotationaldriver;

FIG. 9 is an enlarged view along line 9-9 in FIG. 8;

FIG. 10 is a sectional view along line 10-10 in FIG. 8;

FIG. 11 is a sectional view along line 11-11 in FIG. 9;

FIG. 12 is an enlarged side view of the improved fastener of the presentinvention shown in FIGS. 1-7;

FIG. 13 is a top view of the screw of FIG. 12;

FIG. 14 is a left end view of the screw of FIG. 12 illustrating the tipof the screw;

FIG. 15 is a right end view of the screw of FIG. 12 illustrating thehead of the screw;

FIG. 16 illustrates a first step in securing a tissue to a boneincluding rotating the rotational driver with a suture for inserting afirst screw with a suture into the bone and for cutting the bone tocountersink the head of the screw;

FIG. 17 is an enlarged view of the distal end of the rotational driverof FIG. 16 illustrating the cutting the bone to countersink the head ofthe first screw and then application of the capture so that the capturesits flush with the bone surface;

FIG. 18 is a view similar to FIG. 17 illustrating the free movement ofthe suture through a transverse aperture when the first screw iscompletely embedded into the bone;

FIG. 19 is a top view of FIG. 18;

FIG. 20 illustrates the step of passing a first end of the suturethrough a resilient loop of a capture magazine for threading the firstend of the suture through a capture aperture of a first capture;

FIG. 21 illustrates the capture aperture of the first capture beingmoved along the suture;

FIG. 22 illustrates the step of passing the first end of the suturethrough a central aperture in the driver;

FIG. 23 illustrates the step of pushing the capture with the driveralong the suture to lockingly engage the capture with one of the seriesof protuberances for securing the first end of the suture;

FIG. 24 is an enlarged view of a portion of FIG. 23;

FIG. 25 illustrates the step of inserting a second screw and a sutureshuttle into the bone and for cutting the bone to countersink the headof the second screw;

FIG. 26 illustrates the step of inserting a second end of the sutureinto the loop of the suture shuttle;

FIG. 27 is an enlarged view of FIG. 26 illustrating the free movement ofthe suture shuttle through a transverse aperture when the second screwis completely embedded into the bone;

FIG. 28 illustrates the step of threading the second end of the suturethrough a transverse aperture of the second screw;

FIG. 29 illustrates the second end of the suture threaded through thetransverse aperture of the second screw;

FIG. 30 is an enlarged view of a portion of FIG. 29;

FIG. 31 illustrates the step of passing the second end of the suturethrough the resilient loop of the capture magazine for threading thesecond end of the suture through a capture aperture of a second capture;

FIG. 32 illustrates the step of passing the second end of the suturethrough a central aperture in the driver;

FIG. 33 illustrates the step of pushing the second capture with thedriver along the suture to lockingly engage the second capture with oneof the series of protuberances for securing the second end of thesuture;

FIG. 34 illustrates the second capture lockingly engaged with one of theseries of protuberances the suture;

FIG. 35 is an enlarged view of a portion of FIG. 34 showing the captureflush in the bone;

FIG. 36 is an isometric view of a first example of a suture having aseries of protuberances engaging with a capture aperture of a capture;

FIG. 37 is an isometric view of a first step in a method for forming aprotuberance on a suture illustrating placing a suture to extend througha mold cavity;

FIG. 38 is an isometric view of a second step in the method for formingthe protuberance on the suture illustrating inserting an adhesive intothe mold cavity;

FIG. 39 is an isometric view of a third step in the method for formingthe protuberance on the suture illustrating removing the suture with theadhered protuberance from the mold;

FIG. 40 is an isometric view of a second example of a suture having aseries of protuberances engaging with a capture aperture of a capture;

FIG. 41 is an isometric view of a first step in a method for forming aprotuberance on a suture illustrating placing a suture into a moldhaving a series of mold cavities with each of the mold cavities having aleading edge and a trailing edge contoured for a specific capture;

FIG. 42 is an isometric view of the step of inserting an adhesive intothe mold;

FIG. 43 is an isometric view of the step of removing the suture with theadhered protuberance from the mold;

FIGS. 44-51 illustrate variations within the longitudinal suture orsuture redundancies which allow the adhesive to hold more securely tothe suture and prevent the protuberances from sliding along the lengthof the suture during a tensile load”

FIG. 44 is a sectional view of a third example of a protuberance formedon a suture;

FIG. 45 is a sectional view of a fourth example of a protuberance formedon a suture;

FIG. 46 is a sectional view of a fifth example of a protuberance formedon a suture;

FIG. 47 is a sectional view of a sixth example of a protuberance formedon a suture;

FIG. 48 is a sectional view of a seventh example of a protuberanceformed on a suture;

FIG. 49 is a sectional view of a eighth third example of a protuberanceformed on a suture;

FIG. 50 is a sectional view of a ninth example of a protuberance formedon a suture;

FIG. 51 is a sectional view of a tenth example of a protuberance formedon a suture;

Similar reference characters refer to similar parts throughout theseveral Figures of the drawings.

DETAILED DISCUSSION

FIGS. 1-7 are various views of an apparatus 5 for securing a suture 10to living tissue 20 shown in FIGS. 21-35. In this example, the suture 10has a flexible component 13 and a series of protuberances 14 spacedapart and along a length of the flexible component 13. The flexiblecomponent 13 may be a monofilament or may be a braided flexiblecomponent 13. The protuberances 14 may be formed or molded along thelength of the flexible component 13 or may be knots tied along thelength of the flexible component 13.

The apparatus 5 comprises an improved hand tool shown as a rotationaldriver 35 having a handle 40 supporting a shaft 60. The handle 40includes a first and a second suture retainer 41 and 42 located onopposed sides of the handle 40. A first and a second jam cleat 43 and 44cooperate with the first and second suture retainers 41 and 42 fortemporarily retaining at least one suture 10. In this embodiment, thefirst retainer 41 and first jam cleat 43 retains a first end 11 of thesuture 10 whereas the second retainer 42 and the second jam cleat 44temporarily retains a second end 12 of the suture 10. A first and secondpass through 46 and 47 are defined in the first and second sutureretainers 41 and 42 for passing a suture between opposed sides of thehandle 10. As will be described in greater detail hereinafter, thesuture 10 extends through a screw 100 for enabling the rotational driver35 to rotationally insert a screw 100 into the living tissue 20 whilethe suture extends through the screw 100.

As best shown in FIG. 4, a capture magazine 50 is located on the handle40 in proximity to the juncture of the handle 40 and the shaft 60. Inthis embodiment, the capture magazine 50 is shown storing captures 51-54threaded onto a resilient wire loop 55. The resilient wire loop 55extends through capture orifices within each of the captures 51-54. Aswill be described in greater detail here and after, the resilient wireloop 55 facilitates threading of the suture 10 through the captureorifice in the capture 51.

The shaft 60 extends from a proximal end 61 adjacent to the handle 42 adistal end 62. A socket 64 is defined in the distal end 62 of the shaft60 for receiving the screw 100. Preferably, the screw 100 is retained inthe socket 64 by a functional fit between the socket 64 and the screw100. As will be illustrated hereinafter, the socket 64 of the shaft 60is configured for engaging with a capture 51 for pushing a capture withthe rotational driver 35.

A first and a second slot 71 and 72 are located in the socket 64 at thedistal end 62 of the shaft 60. The suture 10 extends from the screw 100through the first and second slots 71 and 72 to the first and secondsuture retainers 41 and 42 for temporarily retaining the suture 10 withthe socket 64.

FIGS. 8-11 are further views illustrating the rotational driver 35 ofFIGS. 1-7. In this example of the invention, the socket is shown as ahexagonal socket for engaging with screw 100. The first and second slots71 and 72 are located on opposed sides of the hexagonal socket 64. Theedges of the first and second slots 71 and 72 are sharpened to form afirst and a second cutting edge 81 and 82. The first and second cuttingedges 81 and 82 are able to cut through bone tissue upon rotation of therotational driver 35 while simultaneously insert the screw 100.

As best shown in FIGS. 10 and 11 a central orifice 90 is defined in thedistal end 62 of the shaft 60. The central orifice 90 extends from asocket end 91 to a shaft end 92 located at an outer surface of the shaft60 defining a tunnel 93 there between. The tunnel 93 positions a suture10 centrally in the distal end 62 of the shaft 60. The tunnel 93 enablesthe suture 10 to be past through a capture 51 and through the tunnel 93for enabling the rotational driver 35 to push the capture 51 along thesuture 10.

FIGS. 12-15 are enlarged view illustrating the screw 100 of the presentinvention. The screw 100 comprises a screw body 102 having a helicalscrew thread shown as a canellous screw thread 104. The screw body 102extends between a screw tip 106 and a screw head 110. The screw head 110defines a socket shape in an outer periphery of the screw head 110 forenabling the socket 64 of the rotational driver 35 to rotationallyinsert the screw 100 into the living tissue 20. In this example, thescrew head 110 is shown as having a cross-section of a regular polygonand in particular a regular hexagon.

A transverse aperture 115 extends through the screw body 102 of thescrew 100. The transverse aperture 115 is perpendicular to an axis ofrotation (not shown) extending from the screw tip 106 to the screw head110.

A first and a second channel 121 and 122 are recessed into the outerperiphery of the screw head 110 and allow for the insertion of the screwwithout a suture and by using a suture shuttle allow for a suture to bethreaded through the embedded screw after implantation. In this example,the first and second channels 121 and 122 are recessed into opposedsides of the regular hexagon. The first and second channels 121 and 122communicate with the transverse aperture 115 to form a screw pathway 125for the suture 10. The first and second channels 121 and 122 and thetransverse aperture 115 of the screw pathway 125 are dimensioned forenabling the suture 10 to be easily moved and or threaded through thescrew pathway 125 while the screw body 102 including the screw head 110is totally embedded into living tissue 20.

It should be appreciated by those skilled in the art that the screw 100may take various forms and shapes and still obtain the benefit of thepresent invention. For example the length, size and shape of the screwbody screw 102, the screw threads 104, the screw tip 106 as well as thescrew head 110 may be varied depending upon the desired medicaltreatment. Furthermore, the screw pathway 125 comprising the first andsecond channels 121 and 122 and the transverse aperture 115 may takeseveral shapes and sizes for enabling the suture 10 to be easily movedand or threaded through the screw pathway 125.

A specific example of the dimensions of the screw pathway 125 is shownin FIGS. 13 and 15 but should not be construed as being a limitation onthe present invention. The distance [D] between opposed sides of theregular hexagon of the screw head 110 is shown in FIG. 15. Each of thefirst and second channels 121 and 122 has a recess depth [D/3] greaterthan one-third the distance [D] between opposed sides of the regularhexagon of the screw head 110. Each of the first and second channels 121and 122 having a length greater than the distance [D] between opposedsides of the regular hexagon of the screw head 110.

Referring back to FIGS. 1-7, the first and second slots 71 and 72 of thedistal end 62 of the shaft 60 are aligned with the first and secondchannels 121 and 12 of the screw head 110. The suture 10 extends throughthe screw pathway 125 comprising transverse aperture 115 and the firstand second channels 121 and 122 of the screw 110 and into the first andsecond slots 71 and 72 of the shaft 60. The socket 64 is able to engagethe outer periphery 112 of the screw head 110 when the suture 10 extendsthrough the first and second channels 121 and 122 of the screw 110.Furthermore, the first and second channels 121 and 122 in the screw 100permit the suture 10 to extend from the first and second slots 71 and 72of the shaft through the first and second channels 121 and 122 and thetransverse aperture 115 of the screw 100 whiles the first and secondcutting edges 81 and 82 cut the bone 21 to countersink the head 110 ofthe screw 110 within the bone 21.

FIG. 16 illustrates a first step in securing soft tissue 22 to a bone 21including rotating the rotational driver 35 with the suture 10 forinserting the first screw 100A with the attached suture 10 into the bone21 and for cutting the bone 21 to countersink the head 110 of the screw100A.

FIG. 17 is an enlarged view of the distal end of the rotational driver35 of FIG. 16 illustrating the cutting the bone 21 to countersink thehead 110 of the first screw 100A.

FIG. 18 is a view similar to FIG. 17 illustrating the free movement ofthe suture 10 through the transverse aperture 115 when the first screw100A is completely embedded into the bone 21.

FIG. 19 is a top view of FIG. 18 further illustrating the free movementof the suture 10 through the transverse aperture 115.

FIG. 20 illustrates the step of passing the first end 11 of the suture10 through the resilient loop 55 of a capture magazine 50 for threadingthe first end 11 of the suture 10 through a capture aperture 51X of afirst capture 51. The suture 10 bends approximately one hundred andeighty degrees as the first capture 51 is removed from the resilientloop 55 to thread a loop of the suture 10 through the capture aperture51X of a first capture 51.

FIG. 21 illustrates the capture aperture 51X of the first capture 51being moved along the suture 10.

FIG. 22 illustrates the step of passing the first end 11 of the suture10 through the central aperture 90 in the rotational driver 35.

FIG. 23 illustrates the step of pushing the capture 51 with therotational driver 35 along the suture 10 to lockingly engage the capture51 with one of the series of protuberances 14 for securing the first end11 of the suture 10.

FIG. 24 is an enlarged view of a portion of FIG. 23 further illustratingthe locking engagement of the capture 51 with one of the protuberances14 of the suture 10.

FIG. 25 illustrates the step of inserting a second screw 100B and asuture shuttle 30 into the bone 21 and for cutting the bone 21 tocountersink the head 110 of the second screw 100B. The suture shuttle 30extends between a first end 31 and a second end 32 and has a loop 33located at the first end 31. Preferably, the suture shuttle 30 istreaded through the transverse aperture 115 of the second screw 100Bbefore the second screw 100B is inserted into the socket 64 of therotational driver 35.

FIG. 26 illustrates the step of inserting a second end 12 of the suture10 into the loop 33 of the suture shuttle 30.

FIG. 27 is an enlarged view of FIG. 26 illustrating the free movement ofthe suture shuttle 30 through a transverse aperture 115 when the secondscrew 100B is completely embedded into the bone 21.

FIG. 28 illustrates the step of threading the second end 12 of thesuture 10 through the transverse aperture 115 of the second screw 100B.As the suture shuttle 30 is pulled through the transverse aperture 115of the second screw 100B, the loop 33 bends the suture 10 approximatelyone hundred and eighty degrees to form a doubled up suture loop that isthreaded through the transverse aperture 115 of the second screw 100B.The second channels 121 and 122 and the transverse aperture 115 aredimensioned for enabling the doubled up suture loop of the suture 10 tobe easily threaded through the second screw 100B while the second screw100B is totally embedded into the bone 21.

FIGS. 29 and 30 illustrates the second end 12 of the suture 10 threadedthrough the transverse aperture 115 of the second screw 100B. The suture10 is free to move through the second screw 100B while the second screw100 is totally embedded into the bone 21 in order to tighten the suture10 to bring the soft tissue 22 into engagement with the bone 21.

FIG. 31 illustrates the step of passing the second end 12 of the suture10 through the resilient loop 55 of the capture magazine 50 forthreading the second end 12 of the suture 10 through the captureaperture 52X of a second capture 52.

FIG. 32 illustrates the step of passing the second end 12 of the suture10 through a central aperture 90 in the rotational driver 35 after thecapture aperture 52X of the second capture 52 has been moved along thesuture 10.

FIG. 33 illustrates the step of pushing the second capture 52 with therotational driver 35 along the suture 10 to lockingly engage the secondcapture 51 with one of the series of protuberances 14 for securing thesecond end 12 of the suture 10.

FIGS. 34 and 35 illustrate the second capture 52 lockingly engaged withone of the series of protuberances 14 of the suture 10. The suture 10was free to move through the second screw 100B while the second screw100B was totally embedded into the bone 21 in order to tighten thesuture 10 to bring the soft tissue 22 into engagement with the bone 21.

FIG. 36 is an isometric view of a first example of a suture 10A having aseries of protuberances 14A engaging with a capture aperture 56X of acapture 56. A full explanation of the operation and benefit of thiscapture may be found in PCT patent application PCT/U82013/063277 whichis incorporated by reference as if fully set forth herein.

FIG. 37 is an isometric view of a first step in a method for forming aprotuberance 14A on a suture 10A. The mold 130A comprises a first moldand a second mold 131A and 132A defining a first and a second moldcavity 133A and 134A. Feeder tubes 135A communicate with the mold cavity135A for introducing an adhesive 137A one into the mold cavity 135A. Aflexible suture component 13A is placed into the mold cavities 133A and134A to extend through the mold cavity 130A.

FIG. 38 is an isometric view of a second step in the method for formingthe protuberance 14A on the suture 10A illustrating inserting anadhesive 137A into the mold cavities 133A and 134A through the feedertubes 135A.

FIG. 39 is an isometric view of a third step in the method for formingthe protuberance 14A on the suture 10A illustrating removing the suture10A with the adhered protuberance 14A from the mold 130A. Theprotuberances 14A are formed entirely of the adhesive 137A.

FIG. 40 is an isometric view of a second example of a suture 10B havinga series of protuberances 14B engaging with a capture aperture 57X of acapture 57. In this example, each of the protuberances 14B has a leadingedge 141B and a trailing edge 142B. In contrast to the protuberances 14Ashown in FIGS. 36-39, the leading edge 141B is not symmetrical with thetrailing edge 142B. The non-symmetrical design of the protuberances 14Bare specifically designed to engage with the specific capture ataperture 57X of a capture 57.

FIG. 41 is an isometric view of a first step in a method for forming aprotuberance 14B on a suture 10B. The mold 130B comprises a first moldand a second mold 131B and 132B defining a first and a second moldcavity 133B and 134B.

The first and second mold cavity 133B and 134B define a leading moldportion 151B and a trailing mold portion 152B. The leading mold portionand trailing mold portion 151B and 152B correspond to the leading edge141B and the trailing edge 142B of the protuberances 14B. Feeder tubes135B communicate with the mold cavity 130B for introducing an adhesive137B into the mold cavity 130B. A flexible suture component 13B isplaced into the mold cavities 133B and 134B to extend through the moldcavity 130B.

FIG. 42 is an isometric view of a second step in the method for formingthe protuberance 14B on the suture 10B illustrating inserting anadhesive 137B into the mold cavities 133B and 134B through the feedertubes 135B.

FIG. 43 is an isometric view of a third step in the method for formingthe protuberance 14B on the suture 10B illustrating removing the suture10B with the adhered protuberance 14B from the mold 130B. Theprotuberances 14B are formed entirely of the adhesive 137B.

FIGS. 44-51 are sectional views of example of protuberances 14C-14Jformed on a suture 10C-10J. Similar parts are labeled with similarreference numerals and added alphabetical character. Each of the suture10C-10J include a flexible suture component 13C-13J which is the bent,shaped or tied to stabilize the protuberances 14C-14J formed solely froman adhesive 137. The bend shape or knot of the flexible suture component13C-13J provides mechanical strength and prevent slippage of theprotuberances 14C-14J.

FIGS. 36-43 illustrate a specific molding process for forming theprotuberances 14 on a flexible suture component 13 for providing thesuture 10. It should be understood that various other molding processesand or techniques may be utilized for forming the protuberances 14 on aflexible suture component 13. For example, various adhesives may be usedas well as various types of molding techniques such as waffle style andclam shell molds made of metal PTFE, or TEFLON as well as 3-D printingand the like.

The present disclosure includes that contained in the appended claims aswell as that of the foregoing description. Although this invention hasbeen described in its preferred form with a certain degree ofparticularity, it is understood that the present disclosure of thepreferred form has been made only by way of example and that numerouschanges in the details of construction and the combination andarrangement of parts may be resorted to without departing from thespirit and scope of the invention.

What is claimed is:
 1. A method of moving a capture along a suture witha driver, the suture having a series of protuberances spaced apart alonga length thereof, the capture having a central locking aperture formoving over the series of protuberances in a first direction and forresisting moving over the series of protuberances in a second direction,comprising the steps of threading the suture through a central aperturein the capture and through a central orifice in the driver to extendoutside and adjacent to the driver; positioning the central aperture inthe capture in alignment with the central orifice in the driver; andmoving the driver relative to the suture to move the capture along thesuture to lockingly engage the capture with one of the series ofprotuberances.
 2. A method of moving a capture along a suture with adriver having a central orifice, the suture having a series ofprotuberances spaced apart along a length thereof, the capture having acentral locking aperture for moving over the series of protuberances ina first direction and for resisting moving over the series ofprotuberances in a second direction, comprising the steps of: threadingthe suture through the central locking aperture in the capture and acentral orifice in the driver to extend outside and adjacent to thedriver; positioning the central locking aperture in the capture inalignment with the central orifice in the driver; and moving the driverrelative to the suture extending outside of the driver to move thecapture along the suture in the first direction to lockingly engage thecapture with one of the series of protuberances.